Job Overview
Location
Remote (US)
Job Type
Full-time
Category
Product Management
Date Posted
June 3, 2026
Full Job Description
đź“‹ Description
- • Lead end-to-end management of escalated GxP and quality incidents on a global scale, ensuring compliance with FDA, EMA, ISO, WHO, and other regulatory standards.
- • Develop, maintain, and continuously improve quality incident management processes aligned with organizational goals and evolving regulatory requirements.
- • Oversee the intake, triage, investigation, documentation, and resolution of quality-related issues including deviations, non-conformances, and regulatory findings.
- • Drive comprehensive root cause analyses and oversee the development, implementation, and tracking of corrective and preventive actions (CAPAs) for escalated quality incidents.
- • Serve as Subject Matter Expert (SME) and facilitator for Quality Risk Management (QRM) frameworks in alignment with ICH Q9 guidelines.
- • Review and support regulatory CMC submission content related to quality incidents and risk assessments.
- • Collaborate cross-functionally with manufacturing, quality assurance, quality control, regulatory affairs, clinical operations, and patient safety teams to ensure timely resolution of quality issues.
- • Ensure all escalation and notification activities to management meet regulatory documentation requirements and support inspection and audit readiness.
- • Build and expand knowledge management systems and tools to enable rapid access to quality-related data across the product lifecycle in partnership with the Product Data Quality team.
- • Develop and deliver training programs on incident management procedures, promoting a culture of quality, accountability, and continuous improvement.
- • Track key performance indicators (KPIs), analyze incident trends, and provide regular reporting to leadership on quality performance and compliance metrics.
- • Initiate and manage market actions when required due to quality incidents or regulatory findings.
- • Maintain strong PC literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint) and ability to learn specialized platforms including Veeva, Power BI, Calyx, and SAP.
- • Travel up to 20% to support global operations, audits, and cross-functional initiatives.
- • Demonstrate global competencies including fostering teamwork, providing actionable feedback, analytical thinking, results orientation, and clear communication.
🎯 Requirements
- • Bachelor’s degree and 8+ years of experience in quality sciences, quality systems, or related fields within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices)
- • Master’s degree and 10+ years of direct experience preferred
- • 6+ years of managerial experience leading teams, projects, or allocating resources
- • Experience with regulatory interactions including global notifications and communications with health authorities on sensitive compliance topics
- • Proven expertise in GxP, QRM (ICH Q9), CAPA, change control, and quality incident management processes
- • Strong proficiency in MS Office and ability to learn specialized quality systems (Veeva, Power BI, Calyx, SAP)
🏖️ Benefits
- • Annual bonus eligibility for non-commercial roles
- • Eligibility for discretionary equity awards in BeiGene, Ltd. stock
- • Participation in the Employee Stock Purchase Plan
- • Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness programs
Skills & Technologies
About BeiGene, Ltd.
BeiGene is a global biotechnology company discovering, developing, manufacturing and commercializing innovative oncology medicines. Its broad pipeline includes more than 50 clinical-stage molecules, spanning targeted therapy, immuno-oncology and combination regimens. Core products are BTK inhibitor BRUKINSA, PD-1 antibody tislelizumab and PARP inhibitor pamiparib, marketed worldwide through internal teams and strategic alliances. BeiGene operates integrated research campuses in Beijing and Cambridge, MA, a manufacturing facility in Suzhou and offices across North America, Europe and Asia-Pacific, serving patients in more than 45 countries.
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